Australia and New Zealand's role in VICH

Find out about the roles played by Australian and New Zealand (ANZ) representatives when observing meetings of the VICH Standing Committee.


ANZ VICH management group

Establishment of ANZ VICH MG

Following the first meeting of the VICH in April 1996, the ANZ representatives in VICH decided to set up an organisation to implement their observer role on the VICH Standing Committee.

Membership of ANZ VICH MG

(number of seats)

Industry representation:

  • Chairman (also the VICH industry representative)
  • Animal Health Alliance (1) – Australia (also acts as secretariat for the committee)
  • Agcarm (1) – New Zealand
  • ARPPA (1) – New Zealand
  • VMDA (1) – Australia

Regulatory authority representation:

  • Australian Pesticides and Veterinary Medicines Authority (1) – Australia
  • MPI (1) – New Zealand
  • Environmental Protection Authority (1) – New Zealand

The ANZ VICH MG meets twice a year, in concert with the VICH Standing Committee meetings.

Role of ANZ VICH

  • Provide an industry/government forum for the facilitation of ANZ input into the VICH process in areas such as:
    • Nominating ANZ representatives to VICH and its working groups
    • Providing direction on issues as they arise to ANZ representatives on VICH
    • Identifying issues for presentation to VICH
    • Preparing position papers on VICH topics
    • Identifying local coordinators for specialist advice on VICH topics.
  • Promote harmonisation of Australian and New Zealand regulatory requirements for animal health products in line with VICH recommendations and internationally recognised standards
  • Provide advice to the ANZ Registration Management Committee established by the Australian and New Zealand governments in 1997
  • Provide advice to industry and government as appropriate on international harmonisation of regulatory requirements for animal health products
  • Seek coordination of ANZ international activities relating to regulatory requirements for animal health products (eg Codex).

ANZ VICH procedure for input into VICH working

Step a: A working group topic is agreed by the VICH Steering Committee (Step 1).

Step b: ANZ VICH MG seeks nominations for expert/coordinator for the working group.

Step c: ANZ VICH MG agrees on nomination of expert and submits to VICH SC. Where no expert is nominated, a local coordinator is agreed.

Step d: VICH SC establishes membership of working group and agrees on chairman (Step 1).

Step e: In conjunction with the expert/coordinator, ANZ VICH MG identifies peer group (persons from industry and government).

Step f: Expert develops ANZ position paper in conjunction with peer group and submits paper to working group after sign-off by ANZ VICH MG.

Step g: Expert attends meetings of working group.

Step h: Working group circulates draft for comment (Step 4).

Step i: Expert/coordinator collates comments in relation to draft and prepares ANZ response for sign-off by ANZ VICH.

(Steps f to i continue until a final document is agreed by ANZ VICH MG.)

Step j: ANZ response is submitted to the working group (when ANZ has an expert) or to VICH SC (when there is a local coordinator).

ANZ VICH experts/coordinators

There are two participating roles in VICH working groups: experts and coordinators. While the experts interact directly with the appropriate VICH working groups, the coordinators act locally by coordinating an ANZ position on VICH guidelines when an ANZ expert has not been nominated.

Roles of experts

  • Act as the central liaison point for all written and oral communication in relation to the working group
  • Consult with peers in Australia and New Zealand (industry and government), from a listing developed in conjunction with ANZ VICH MG
  • Prepare de novo an ANZ submission to the working group, which incorporates the views of industry and government.
  • Consolidate responses within ANZ on guidelines and provide recommendations for submission to the working group
  • Provide ANZ VICH MG with appropriate comment on the working group deliberations and decisions
  • Attend meetings of the working group as the ANZ representative
  • As appropriate, attend meetings of ANZ VICH MG to report on working group activities
  • Obtain ANZ VICH MG approval for documents to be submitted to the working group.

Roles of coordinators

  • Liaise with the ANZ VICH secretariat for all communications with VICH in relation to the working group
  • Act as the central liaison point for all written and oral communication in relation to the working group documents received through ANZ VICH MG
  • Consult with peers in Australia and New Zealand (industry and government), from a listing developed in conjunction with ANZ VICH MG
  • Prepare the ANZ submission to VICH, which incorporates the views of industry and government
  • As appropriate, attend meetings of ANZ VICH MG to report on working group activities
  • Obtain ANZ VICH MG approval for documents to be submitted to the working group.

Benefits of VICH for Australia and New Zealand

Regulatory certainty

  • Uniform requirements
  • Predictable regulatory environment
  • Time limits for regulatory process
  • Economics of scale
  • Scientific principles rather than socio-economic considerations the mainstay of the approval process.

Reduced animal testing

  • Elimination of duplicate testing
  • Introduction of uniform in vitro testing methods.

Ready-made model

  • VICH model offers framework for harmonisation
  • Adapts human pharmaceutical work to veterinary sector
  • Complements work of Codex and JECFA.

Removal of trade barriers

  • Harmonisation leads to increased free trade
  • Applies to both veterinary and food products
  • Observer countries are major food exporters.

Consumer safety

  • Requirements based on scientific principles reinforce credibility of regulatory process and food standards.
  • Transparent and uniform process improves consumer perceptions of and confidence in food safety.

Broader harmonisation

  • Extends EU/US/Japan harmonisation initiatives
  • Participation in VICH promotes regional harmonisation.

Cost efficiencies

  • Avoids duplication
  • Reduction in R&D expenditure
  • Reduction in R&D timeframes
  • Development of drugs with limited market potential.
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